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Zinc and Iron Bioavailability From Biofortified Pearl Millet

NCT01783067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-04-28

No results posted yet for this study

Summary

Populations who consume non-fortified plant-based diets are at increased risk of iron and zinc deficiencies. The purpose of this randomized controlled study is to determine the absorption of iron and zinc from pearl millet biofortified with these two micronutrients. Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron absorbed are measured with established stable isotope extrinsic labeling techniques and analyses of duplicate diets.

Conditions

  • Nutritional Deficiency

Interventions

OTHER

Pearl millet

Participants in the control arm consume pearl millet which has not been biofortified. The intervention is consumed for two days.

OTHER

Biofortified pearl millet

Participants in the experimental arm consume pearl millet biofortified with iron and zinc. The intervention is consumed for two days.

Sponsors & Collaborators

  • Jawaharlal Nehru Medical College

    collaborator OTHER

  • HarvestPlus

    collaborator OTHER

  • International Atomic Energy Agency

    collaborator OTHER_GOV

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Michael Hambidge, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01783067 on ClinicalTrials.gov